Is Gilteritinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Gilteritinib, including Xospata (40 mg, Film-coated tablet, SAR 72743.35).

Is Gilteritinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Gilteritinib, including XOSPATA (Prescription).

Is Gilteritinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Gilteritinib: Xospata.

Are there safety signals or safety updates for Gilteritinib?

US FDA: 1 entry (latest 2022-01-12).

Active substance

Gilteritinib

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Xospata	40 mg	Film-coated tablet · Oral use	84 Blister	SAR 72743.35	NCE · Prescription	Astellas Pharma Europe B.V.	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML)

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XOSPATA	EQ 40MG BASE	tablet · oral	ASTELLAS	Prescription	28 Nov 2018

EMA European Union — centrally authorised medicines

Xospata Astellas Pharma Europe B.V. · Authorised · authorised 24 Oct 2019 · ATC L01EX13

Therapeutic indication (EMA)

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XOSPATA	02495058	40 MG	TABLET · ORAL	ASTELLAS PHARMA CANADA INC

Safety signals and safety-related labeling changes

US FDA 12 Jan 2022 XOSPATA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for gilteritinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.